Complementary and Integrative Therapy for Diabetic Neuropathy (CIT-DN)

July 16, 2012 updated by: Heidemarie Haller, Universität Duisburg-Essen

Effectiveness of a Complementary and Integrative Therapy in Diabetic Neuropathy Patients.

Despite the long tradition of complementary and alternative medicine (CAM) therapies there are hardly any interventional trials on type 2 diabetes mellitus. Hence this pilot study aims to investigate the influence of a two weeks integrative inpatient therapy on the quality of life in 50 patients suffering from diabetic neuropathy. Integrative treatment includes aspects of conventional and traditional European and Chinese medicine, mind-body medicine, physical therapy and lifestyle modification (nutrition advices, stress management and exercise training). The observational design intends four measurement points: tree months before (T0), directly before (T1), directly after treatment (T2) and three months follow-up (T3). The subjective evaluation of the neuropathy-related quality of life was combined with neurophysiologic instruments (QST), to measure neuropathic symptoms. Also pain intensity, locus of control, interpretation of illness, coping style, anxiety/depression, life satisfaction and several biomarkers (HbA1c, ABI, WHR and BMI) are measured. In addition a qualitative interview should give a view to patient perspective of therapy process.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

6

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • NRW
      • Essen, NRW, Germany, 45276
        • Kliniken Essen-Mitte

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

primary care clinic

Description

Inclusion Criteria:

  • over 18 years old
  • diabetes mellitus type 2

Exclusion Criteria:

  • diabetes mellitus type 1
  • pregnancy
  • oncologic diseases
  • systemic neurological diseases
  • other induced neuropathy (radicular, s/p alcohol abuse, chemotherapy-induced)
  • other severe psychiatric or somatic comorbidity

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
type 2 diabetics with neuropathy
Other: inpatient integrative treatment
two weeks inpatient integrative therapy: conventional medicine, traditional European and Chinese medicine (TCM), mind-body medicine, physical therapy, lifestyle modification program: nutrition advices, stress management, exercise training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuropathy-related Quality of Life (QOL-DN)
Time Frame: at T2
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
at T2
Neuropathy-related Quality of Life (QOL-DN)
Time Frame: at T3
Norfolk Quality of Life Questionnaire (Vinik et al. 2008)
at T3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantitative Sensory Testing (QST)
Time Frame: at T2 and T3
  • Thermal detection thresholds (CDT, WDT), thermal pain thresholds (CPT, HPT) and paradoxical heat sensations (PHS)
  • Mechanical detection threshold (MDT), mechanical pain threshold (MPT), mechanical pain sensitivity (MPS), dynamic mechanical allodynia (ALL) and wind-up ratio (WUR)
  • Vibration detection threshold (VDT)
  • Pressure pain threshold (PPT) (Rolke et al. 2006)
at T2 and T3
Pain intensity (VAS)
Time Frame: at T2 and T3
100mm Visual Analogue Scale
at T2 and T3
Control Beliefs (MHLC / short form)
Time Frame: at T2 and T3
Short form of the Multidimensional Helath Locus of Control Scale (Hasenbring 1988)
at T2 and T3
Interpretation of Illness (IIQ)
Time Frame: at T2 and T3
Interpretation of Illness Questionnaire (Büssing et al. 2009)
at T2 and T3
Coping Style (AKU)
Time Frame: at T2 and T3
Short form of the Adaptive Coping with Disease Questionnaire (Büssing et al. 2010)
at T2 and T3
Anxiety and Depression (HADS)
Time Frame: at T2 and T3
Hospital Anxiety and Depression Scale (Herrmann et al. 1995)
at T2 and T3
Life Satisfaction (SWLS)
Time Frame: at T2 and T3
Satisfaction with Life Scale (Diener et al. 1995)
at T2 and T3
Blood sugar Level (HbA1c)
Time Frame: at T2 and T3
at T2 and T3
Waist-to-Hip Ratio (WHR) and Body Mass Index (BMI)
Time Frame: at T2 and T3
at T2 and T3

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universität Duisburg-Essen

Investigators

  • Principal Investigator: Gustav J. Dobos, Prof. MD, University of Duisburg-Essen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

July 1, 2012

Study Registration Dates

First Submitted

February 14, 2011

First Submitted That Met QC Criteria

February 14, 2011

First Posted (Estimate)

February 15, 2011

Study Record Updates

Last Update Posted (Estimate)

July 17, 2012

Last Update Submitted That Met QC Criteria

July 16, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10-4517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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